Costs of health care consumption and sick leave 2006 in Sweden for Whiplash Associated Disorders (WAD) was estimated to be 4 billion Swedish crowns. Despite tremendous costs and personal sufferings there are only a few prospective randomized studies (RCT) in patients with chronic WAD, and none of them evaluating return to work, or the role of neck specific exercises with or without a combination of a behavioral approach compared with prescribed physical activity.

Aim:

The general aim of this RCT is to examine what neck-specific training with or without a combination with behavioral approach adds to prescribed physical activity of persons with chronic WAD with regard to pain intensity, physical and psychological function, health care consumption and return to work. Another aim is to study predictive factors of importance for a good outcome of rehabilitation.

Method:

After informed consent patients in age 18-63 years of age with WAD II-III with more than 6 months duration will be randomized to one out of the three alternatives of physiotherapy, treatment with medical exercise therapy with neck specific exercises (A),treatment with a behavioral approach combined with neck specific exercises (B), prescribed physical activity (C). Randomisation will be done by the central project leader. 200 patients will be included in the study. All physiotherapists engaged in the structured and well described treatment will be introduced in the program by the project leader. The measurements with good clinometric properties will be performed before treatment, after 12 weeks, 6, 12 and 24 months after inclusion into the study. Clinical measurements will be performed by a blinded investigator. Background data, disease-specific and generic data will be measured by self-evaluated answered questionnaires by the patients. Days of sick-leave will be collected from the Social Insurance Agency. Main outcomes of the measurements are pain intensity, neck specific disability and return to work. Cost-effectiveness will be calculated.

Neck Disability Index (NDI) [ Time Frame: Baseline and change after 3 and 6 months of exercises, 3 month, 6 month, 12 month and 24 month follow-up. Change from baseline to follow-ups. Twelve month follow-up is the most important follow-up to investigate change over time from baseline. ] [ Designated as safety issue: No ]

NDI will be measured at baseline before intervention. Change from baseline in NDI will be measured at 3,6,12,and 24 months to investigate change over time. Baseline and change after three and six months of exercises and to investigate if a potential change of the exercises remain at 12 month and 24 month from baseline.

Secondary Outcome Measures:

Pain intensity on VAS [ Time Frame: before intervention, 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]

Pain intensity is measured on a 100mm Visual Analogue Scale (VAS).

Pain Disability Index [ Time Frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]

Neck muscle endurance in seconds [ Time Frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]

Self-efficacy scale [ Time Frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]

Work Ability Index [ Time Frame: before intervention and at 3, 6, 12 months and 24 months follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]

Euroquol [ Time Frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]

SF-36 [ Time Frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]

Pain Catastrophizing Scale [ Time Frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]

Tampa Scale 11, short version [ Time Frame: before intervention, 6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]

Neurological status [ Time Frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]

Pain drawing [ Time Frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]

For the pain-drawing task, patients indicated the extent and the distribution of their pain on outlines of full front and back views of a human body. After the patients completed each pain-drawing, the distributions of symptoms will be coded on a seven-point scale (were 0 is no pain, and 6 is pain distributed in the hand), and where the pain was located in the cervical, thoracic, and/or the lumbar spine, in the front and the back of the body, will be indicated using a clear overlay template.

Clinical objective measures [ Time Frame: before intervention, 3,6, 12, and 24 months follow-ups. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]

Range of motion of the neck and cervical kinesthesia (ability to reproduce the neutral head position from 30° cervical rotation with the eyes closed) will be measured with Cervical range of motion device (CROM).

Systematic disease or another injury contraindicated to perform the treatment program or the measurements.

Diagnosed severe psychiatric disorder

Unconscious in connection to the trauma

Known drug abuse

Lack of familiarity with the Swedish language

Contacts and Locations

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528579